Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery

Anomaly; Shoulder Clinical Trial

— PSOASS  

Official title:

Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01621555
• Other study ID #: PSOASS1
• Status: Not yet recruiting
• Phase: N/A
• First received: June 14, 2012
• Last updated: June 14, 2012
• Start date: August 2012
• Est. completion date: November 2014

Study information

• Verified date: June 2012
• Source: NHS Fife
• Contact: ANTHONY H DAVIS, MBCHB FRCA
• Phone: 01592643355
• Email: ANTHONYDAVIS[@]NHS.NET
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery.

Description:

Arthroscopic shoulder surgery is increasingly performed on a daycase basis. Optimal pain relief is the goal as this not only improves patient comfort and allows expedient discharge from hospital, but also reduces the risk of developing postoperative chronic pain and may improve surgical outcome. However, optimal postoperative pain control in daycase surgery remains a challenge. There is considerable variation in the level of postoperative pain experienced between individuals and subsequent analgesia requirements. Previous studies have attempted to predict the level of postoperative pain an individual will experience, using a variety of complex preoperative pain and psychological assessments. Other investigators have focused on a simpler approach, by testing an individual's pain threshold to a single preoperative nociceptive (painful) stimulus, e.g. heat or pressure. Recent work has produced a simple questionnaire alternative to pain intensity testing, the Pain Sensitivity Questionnaire (PSQ). We hypothesise that a patient's pain sensitivity preoperatively may both affect the level of pain they experience postoperatively and their final surgical outcome.

The aim of our study is to correlate a patient's pain sensitivity, as measured by the Pain Sensitivity Questionnaire, with the degree of acute postoperative pain (first 4 days) they experience and subsequent surgical outcome at 6 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent.

Exclusion Criteria:

• Unable to give informed consent

• Documented sensory abnormality (e.g. peripheral neuropathy)

• Contraindication to proposed anaesthetic/analgesic regimen

• No telephone or unable to communicate in English

• Documented psychiatric disorder

• Documented/suspected substance abuse

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anomaly; Shoulder

Locations

Country	Name	City	State
United Kingdom	NHS FIFE	Kirkcaldy	Fife

Sponsors (1)

Lead Sponsor	Collaborator
NHS Fife

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.		6 months	No
Secondary	The degree of correlation between Pain Sensitivity Questionnaire scores and 'Area Under the Curve (AUC)' for postoperative pain experienced (generated from the VAS scores over 4 postoperative days).		6 months	No
Secondary	• The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score.		6 months	No